White, oval-shaped film-coated tablet, engraved “SCAN” on one side and plain on the other side.

PHARMACODYNAMICS

– Ciprofloxacin 500mg is a fluoroquinolone antibacterial with a wider spectrum of activity than nalidixic acid, and more favourable pharmacokinetics allowing its use in systemic infections.

– Ciprofloxacin 500mg is bactericidal and acts by inhibiting DNA gyrase and topoisomerase IV, which are essential enzymes In the reproduction of bacterial DNA.

– Ciprofloxacin 500mg may be active in vitro against some gram-negative aerobic bacteria: Escherichia coli and Citrobacter, Enterobacter, Klebsiella, Proteus, Salmonella, Serratia, Yersinia. It may also exhibit activity against Pseudomonas aeruginosa and Neisseria gonorrhoeae, H. Influenzae, Moraxella catarrhalis.. and grampositive aerobic bacteria: Staphylococci, penicillinase-producing and penicillinase-nonproducing strains, and against some MRSA. Most anaerobic bacteria, including Bacteroides fragilis and Clostridium difficile, are resistant to ciprofloxacin, although some other Clostridium spp. may be susceptible.

PHARMACOKINETICS

– Scanax 500mg ( Ciprofloxacin 500mg ) is rapidly and well absorbed from the gastrointestinal tract. Oral bioavailability is about 70 to 80% and a peak serum concentration of about 2.4 mcg/ml occurs 1 to 2 hours after a 500 mg oral dose.

– Plasma protein binding ranges from 20 to 40%. Ciprofloxacin is widely distributed in the body and tissue penetration is generally good. It appears in the CSF, but concentrations are only about 10% of those in serum when the meninges are not inflamed. Ciprofloxacin crosses the placenta and is also distributed into breast milk. High concentrations are achieved in bile.

– The elimination half-life is about 3 to 5 hours and there is evidence of modest accumulation. Half-life may be prolonged in renal impairment (a value of 8 hours has been reported in end-stage renal disease) and to some extent in the elderly. However, no dose adjustment is usually necessary in these patient unless it is severe.

– Ciprofloxacin 500mg is eliminated principally by urinary excretion, but non-renal clearance may account for about one-third of elimination and includes hepatic metabolism, biliary excretion, and possibly transluminal secretion across the intestinal mucosa. Oxociprofloxacin appears to be the major urinary metabolite and sulfociprofloxacin the primary faecal metabolite. About 40 to 50% of an oral dose is excreted unchanged in the urine and about 15% as metabolites. Faecal excretion over 5 days has accounted for 20 to 35 % of an oral dose.

– Transient increases in serum creatinine have occurred when ciprofloxaun it is with ciclosponn; altered serum concentrations of phenytoin have been reported patients also receiving ciprofloxacin

PREGNANCY AND LACTATION

Pregnancy

Scanax 500mg is only used for pregnancy with severe infection that was not manageable with therapeutic dosages of other antibiotic agents, use of fluoroquinolones is an obligatory therapy.

Lactation

Ciprofloxacin is excreted in human milk Because of the potential tor senous. adverse reactions in infants nursing from mother taking ciprofloxacin if continued use is considered obligatory, mother should discontinue nursing

EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES

The ability to drive or operate machinery may be impaired especially when alcohol is also taken.

In the event of acute overdosage, reversible renal toxicity has been reported in some cases.

Treatment

The stomach should be emptied by inducing vomiting or by gastric lavage The patient should be carefully observered and given supportive treatment including monitoring of renal function and administration of magnes aluminum, or calcium containing antacids which can reduce the absorption of Ciprofloxacin Adequate hydration must be maintained. Only a small amount of ciprofloxacin (< 10%) is removed from the body after hemodialysis or peritoneal dialysis

STORAGE : Store in a well-closed container, in dry place, protect from light Do not store above 300 C